NCT01285544

Brief Summary

There will be no significant differences in the efficacy and tolerability between the test and reference formulations of atorvastatin 20 mg in these Korean adults with primary hypercholesterolemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 28, 2011

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

10 months

First QC Date

January 9, 2011

Last Update Submit

December 15, 2013

Conditions

DyslipidemiaCardiovascular DiseaseHypercholesterolemia

Keywords

statinscholesterolhypercholesterolemiaatorvastatinDyslipidemia in cardiovascular disease (KoLipinon)

Outcome Measures

Primary Outcomes (1)

  • the percent change of LDL-C level

    After taken medication for 8 weeks

Secondary Outcomes (1)

  • the percent change in total cholesterol, triglyceride, high density lipoprotein cholesterol (HDL-C) level, apolipoprotein B/A1 ratio, LDL/HDL ratio, small dense LDL fraction, high-sensitive C reactive protein (hs-CRP)

    After taken medication for 8 weeks

Study Arms (2)

Lipinon-test formulation of atrovastain - 20mg

EXPERIMENTAL
Drug: Atorvastatin (Lipinon)

Lipitor- branded formuation of atorvastatin-20mg

ACTIVE COMPARATOR
Drug: Atorvastatin (Lipitor)

Interventions

Atorvastatin (Lipinon)DRUG

treatment of dyslipidemia administration : PO, qod

Lipinon-test formulation of atrovastain - 20mg
Atorvastatin (Lipitor)DRUG

treatment of dyslipidemia administration : PO, qod

Lipitor- branded formuation of atorvastatin-20mg

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the patients aged 20 to 79 years with primary hypercholesterolemia that was not sufficiently responsive to therapeutic lifestyle changes and had LDL-C level over 100 mg/dL in high risk group.

You may not qualify if:

  • therapy with any other investigational drug within 30 days of randomization,
  • history of hypersensitivity to HMG-CoA reductase inhibitors,
  • uncontrolled hypertension,
  • poorly controlled diabetes (glycosylated hemoglobin \[HbA1c\] \>9%),
  • unstable angina or presented with new-onset myocardial infarction (within 6 months),
  • creatinine \>2.5 mg/dl,
  • alanine aminotransferase (ALT) \>2 x upper limit of normal (ULN), aspartate aminotransferase(AST) \>2 x ULN, or creatine kinase (CK) \>2 x ULN,
  • history of malignancy or psychosis;
  • chronic liver disease,
  • drug or alcohol abuse, pregnancy, breastfeeding, failure to practice adequate contraception, cyclical hormonal contraceptives or intermittent use of hormone replacement therapies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Kim SH, Seo MK, Yoon MH, Choi DH, Hong TJ, Kim HS. Assessment of the efficacy and tolerability of 2 formulations of atorvastatin in Korean adults with hypercholesterolemia: a multicenter, prospective, open-label, randomized trial. Clin Ther. 2013 Jan;35(1):77-86. doi: 10.1016/j.clinthera.2012.11.009. Epub 2012 Dec 28.

    PMID: 23274145DERIVED

MeSH Terms

Conditions

DyslipidemiasCardiovascular DiseasesHypercholesterolemia

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperlipidemias

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2011

First Posted

January 28, 2011

Study Start

September 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

KR(1)